search
Back to results

Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies

Primary Purpose

Vocal Cord Dysfunction, Speech Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GlenXRose Virtual Reality Speech Therapies
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocal Cord Dysfunction focused on measuring Vocal, Speech, Speech-Language Pathology, Virtual Reality, VR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults receiving speech-language therapy at the Glenrose Rehabilitation Hospital (Edmonton, AB, Canada; Alberta Health Services) Presence of a speech disorder Proficiency in English Able to provide signed informed consent to participate in the study Exclusion Criteria: Severe cognitive impairments and/or behavioural impairments Communication disorders that impact comprehension of verbal commands and understanding of scale used in the study Previous history of neurological or psychiatric disorder Substance use disorders

Sites / Locations

  • Glenrose Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Delivered Therapy + Standard Clinical Care

Standard Clinical Care

Arm Description

The GlenXRose virtual reality therapies will be delivered to participants using a head-mounted device to allow vocal therapy and practice. Participants will also receive routine clinical care provided by speech-language pathologists.

Participants will receive routine clinical care provided by speech-language pathologists.

Outcomes

Primary Outcome Measures

Change in Frequency and Treatment Adherence Rates
Reported Frequency of Rehabilitation Therapy
Change in Generalization
Self-reported time using voice production techniques
Change in Compliance Rate
Self-reported time (using a visual analog scale)
Change in Voice Handicap Index - 10
Quantification of participant reported perspectives of voice impairment(s)
Change in Acoustic Analysis of Voice
Conducted by Registered Speech-Language Pathologists (as part of standard care)

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
September 21, 2023
Sponsor
University of Alberta
Collaborators
Alberta Health services
search

1. Study Identification

Unique Protocol Identification Number
NCT05695131
Brief Title
Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies
Official Title
Clinical Implementation, Feasibility, & Validation of the Virtual Reality Delivered GlenxRose Speech-Language Therapies to Improve Patient Adherence and Treatment Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Factors related to successful rehabilitation are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Furthermore, surrounding salience, patients may lose interest or find an intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for the patient but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes. One avenue to increase patient adherence is through the gamification of rehabilitation therapies using virtual reality (VR). Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the immersive experience achieved through VR can further promote salience and be customizable to individual patient requirements. As VR systems are now highly portable and relatively simple to utilize, they can provide an excellent opportunity to continue rehabilitation practice on the home front. Overall, the VR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes. The GlenXRose VR-delivered speech-language therapies (Cognitive Projections Lab, University of Alberta) have been developed and piloted in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with vocal therapy. The proposed studies are to investigate the feasibility of implementing this technology in routine clinical care (specific to voice disorders), obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose VR speech-language therapies on patient adherence and clinical outcomes, compared to traditional clinical care.
Detailed Description
Nonadherence to Speech-Language rehabilitation can result in suboptimal vocal recovery or compensation methods while impacting the quality of life and further burdening the healthcare system. In addition to traditional face-to-face voice therapy, many patients are further given daily voice exercises to practice at home. It is estimated that 38-74% of patients are nonadherent to voice therapies (Ebersole et al., 2018); with such a large prevalence, opportunities to prevent and mitigate nonadherence to voice therapy can significantly promote clinical/functional outcomes. In a recent meta-analysis, it is reported that methods increasing adherence to speech-language rehabilitation further promote home practice (Bartlett et al., 2022). One identified method of promise includes technological approaches (Bartlett et al., 2022) such as the GlenXRose VR Speech-Language therapies (VR-SLP). Purpose & Objective: The GlenXRose VR-SLP program, developed by the Cognitive Projections lab at the University of Alberta in collaboration with the Glenrose Rehabilitation Hospital, provides patients with gamified vocal exercises, therapies, and education delivered through immersive virtual reality. With the degree of VR portability, patients will be able to take the equipment home to facilitate at-home vocal practice. The objective of these studies is to examine the feasibility of implementing the previously developed GlenXRose VR Speech Language therapies (VR-SLP) to routine clinical care delivered by Speech-Language Pathologists to patients with vocal cord disorders. The variables of patient adherence to treatment as well as preliminary effects on vocal measurements (Voice Handicapped Index - 10; Acoustic Analysis of Voice) will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Dysfunction, Speech Disorders
Keywords
Vocal, Speech, Speech-Language Pathology, Virtual Reality, VR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Study 1: Single-Subject Experimental Design Studies will be Implemented (A-B Design) Study 2: Feasibility randomized controlled trial (control and intervention groups)
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be masked to group allocation (VR-delivered therapy + standard care, or traditional standard care alone). Participants will be asked by a research assistant not to reveal details of the group allocation prior to assessments.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Delivered Therapy + Standard Clinical Care
Arm Type
Experimental
Arm Description
The GlenXRose virtual reality therapies will be delivered to participants using a head-mounted device to allow vocal therapy and practice. Participants will also receive routine clinical care provided by speech-language pathologists.
Arm Title
Standard Clinical Care
Arm Type
No Intervention
Arm Description
Participants will receive routine clinical care provided by speech-language pathologists.
Intervention Type
Device
Intervention Name(s)
GlenXRose Virtual Reality Speech Therapies
Intervention Description
Speech therapies for vocal cord disorders have been developed for virtual reality implementation. These include various games to interact with in a virtual environment while conducting rehabilitation therapy, in addition to educational visualizations
Primary Outcome Measure Information:
Title
Change in Frequency and Treatment Adherence Rates
Description
Reported Frequency of Rehabilitation Therapy
Time Frame
Up to 12 Weeks
Title
Change in Generalization
Description
Self-reported time using voice production techniques
Time Frame
Up to 12 Weeks
Title
Change in Compliance Rate
Description
Self-reported time (using a visual analog scale)
Time Frame
Up to 12 Weeks
Title
Change in Voice Handicap Index - 10
Description
Quantification of participant reported perspectives of voice impairment(s)
Time Frame
Up to 12 Weeks
Title
Change in Acoustic Analysis of Voice
Description
Conducted by Registered Speech-Language Pathologists (as part of standard care)
Time Frame
Up to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults receiving speech-language therapy at the Glenrose Rehabilitation Hospital (Edmonton, AB, Canada; Alberta Health Services) Presence of a speech disorder Proficiency in English Able to provide signed informed consent to participate in the study Exclusion Criteria: Severe cognitive impairments and/or behavioural impairments Communication disorders that impact comprehension of verbal commands and understanding of scale used in the study Previous history of neurological or psychiatric disorder Substance use disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Rios Rincon, PhD, R.OT
Phone
780.492.5150
Email
aros@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Figeys, PhD, RN
Phone
780.735.6296
Email
figeys@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Rios Rincon, PhD, R.OT
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Miguel Cruz, DrSc
Organizational Affiliation
University of Alberta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James Raso, MASc
Organizational Affiliation
Glenrose Rehabilitation Hospital, Alberta Health Services
Official's Role
Study Chair
Facility Information:
Facility Name
Glenrose Rehabilitation Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Raso, MASc
Phone
7807357964
Email
james.raso@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Mathieu Figeys, PhD, RN
Phone
780.735.6296
Email
figeys@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15475780
Citation
Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.
Results Reference
background
PubMed Identifier
35320678
Citation
Bartlett RS, Carpenter AM, Chapman LK. A Systematic Review of Adherence Strategies for Adult Populations in Speech-Language Pathology Treatment. Am J Speech Lang Pathol. 2022 May 10;31(3):1501-1516. doi: 10.1044/2022_AJSLP-21-00255. Epub 2022 Mar 23.
Results Reference
background
PubMed Identifier
28709763
Citation
Ebersole B, Soni RS, Moran K, Lango M, Devarajan K, Jamal N. The Role of Occupational Voice Demand and Patient-Rated Impairment in Predicting Voice Therapy Adherence. J Voice. 2018 May;32(3):325-331. doi: 10.1016/j.jvoice.2017.06.002. Epub 2017 Jul 11.
Results Reference
background
PubMed Identifier
27965879
Citation
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
Results Reference
background
Links:
URL
https://www.ualberta.ca/rehabilitation/research/rehabilitation-robotics/current-projects/cogpro-virtual-reality.html
Description
Cognitive Projections Laboratory, University of Alberta

Learn more about this trial

Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies

We'll reach out to this number within 24 hrs